New Study Suggests Cymbalta(R) Reduced Depression Symptoms At Least As Fast As a Leading Competitor
14 December 2005 - 1:00AM
PR Newswire (US)
INDIANAPOLIS, Dec. 13 /PRNewswire-FirstCall/ -- Cymbalta(R)
(duloxetine hydrochloride) reduced symptoms of depression at least
as fast as Lexapro(R) (escitalopram) by the end of two weeks,
according to results from the first head-to-head study comparing
the two antidepressants. The results were released by Eli Lilly and
Company at a meeting of a major scientific society. In this
eight-week study, Cymbalta, a serotonin and norepinephrine reuptake
inhibitor, was effective in reducing depression symptoms (defined
as onset of efficacy) by two weeks for 42 percent of patients.
Within the same time period, 35 percent of patients taking Lexapro,
a selective serotonin reuptake inhibitor, and 22 percent of
patients who received a sugar pill had 20 percent reduction of
symptoms. While not indicative of faster onset of action than
Lexapro in patients with major depressive disorder, this study
showed Cymbalta's onset to be at least as fast as that of Lexapro.
While Cymbalta was significantly better than sugar pill at reducing
depression symptoms, Lexapro was not in this study. In other
studies Lexapro has shown significant improvement versus sugar pill
in reducing depression symptoms. "Previous data has shown that
Cymbalta may work as early as one week. In this study Cymbalta
works at least as fast as Lexapro," says John Greist, M.D.,
clinical professor of psychiatry, University of Wisconsin Medical
School. "This study was the first to compare Cymbalta with Lexapro,
and the first to measure onset of efficacy of Cymbalta as compared
to an SSRI," says Madelaine Wohlreich, M.D., medical advisor for
Eli Lilly and Company. Additional study highlights * The
percentages of patients who responded to treatment with Cymbalta,
Lexapro or sugar pill (48.7 percent, 45.3 percent and 36.9 percent,
respectively) were statistically no different. * Percentage of
patients achieving remission on Cymbalta, Lexapro or sugar pill
(40.1 percent, 33.0 percent and 27.7 percent, respectively) were
statistically no different in this study. * Cymbalta and Lexapro
both had statistically significant changes in the Clinical Global
Impression of Severity (CGI-S) scale and the self- reported Patient
Global Impression of Improvement (PGI-I) scale, when compared with
sugar pill. * Patients taking Cymbalta experienced more side
effects, including nausea and dry mouth, compared with those taking
Lexapro and sugar pill, but the rates at which patients dropped out
of the study because of side effects were statistically no
different (7.3 percent for Cymbalta, 5.1 percent for Lexapro and
5.8 percent for sugar pill). Methods A total of 684 patients with
major depressive disorder aged 18 years and older participated in
the eight-week, multi-center, double-blind, placebo- controlled
clinical trial, conducted entirely within the United States from
November 2003 to May 2005. The patients were randomized to receive
either 60 mg of Cymbalta once daily (n=273), 10 mg of Lexapro once
daily (n=274), or a sugar pill once daily (n=137). Onset of
efficacy was defined as at least a 20 percent decrease from
baseline in the Maier subscale of the Hamilton Depression Scale
(HAM-D17) that was maintained at each visit. Secondary measures
included the Hamilton Anxiety Ratings Scale (HAMA), CGI-S and
PGI-I. Standard safety measures were also collected. This is the
only study that has compared Cymbalta and Lexapro. The study
compared Cymbalta at its highest approved dose of 60 mg per day to
Lexapro's lowest approved dose of 10 mg per day, however those
doses represent the recommended therapeutic doses of each
medication and are widely used. About Depression Up to 19 million
Americans have depressive disorders, including major depression.(i)
It can happen to anyone of any age, race or ethnic group, however
women are nearly twice as likely to experience depression as
men.(ii) Although it is one of the most frequently seen psychiatric
disorders in the primary care setting, it often goes undiagnosed,
or is under-treated.(iii) This may be because depressed patients
often present physical symptoms rather than emotional complaints.
In one study, nearly 70 percent of patients diagnosed with
depression reported physical symptoms as their chief reason for
seeking help.(iv) About Cymbalta Serotonin and norepinephrine in
the brain and spinal cord are believed to both mediate core
depression symptoms and help regulate the perception of pain.
Disturbances of serotonin and/or norepinephrine may explain the
presence of both the emotional and physical symptoms of depression.
Based on pre-clinical studies, duloxetine is a balanced and potent
reuptake inhibitor of serotonin and norepinephrine. While the
mechanism of action of duloxetine is not fully known, scientists
believe its effect on both emotional symptoms and pain perception
is due to increasing the activity of serotonin and norepinephrine
in the central nervous system. Cymbalta is approved in the United
States for the treatment of major depressive disorder and the
management of diabetic peripheral neuropathic pain, both in adults.
Cymbalta is not approved for use in pediatric patients. Important
Safety Information In clinical studies, antidepressants increased
the risk of suicidal thinking and behavior in children and
adolescents with depression and other psychiatric disorders. Anyone
considering the use of Cymbalta or any other antidepressant in a
child or adolescent must balance the risk with the clinical need.
Patients who are starting therapy should be observed closely for
worsening depression symptoms, suicidal thoughts or behavior, or
unusual changes in behavior. Cymbalta is not approved for use in
patients under the age of 18. Patients on antidepressants and their
families or caregivers should watch for worsening depression
symptoms, unusual changes in behavior and thoughts of suicide, as
well as for anxiety, agitation, panic attacks, difficulty sleeping,
irritability, hostility, aggressiveness, impulsivity, restlessness,
or extreme hyperactivity. Call the doctor if you have thoughts of
suicide or if any of these symptoms are severe or occur suddenly.
Be especially observant at the beginning of antidepressive
treatment or whenever there is a change in dose. Prescription
Cymbalta is not for everyone. People who are allergic to Cymbalta
or the other ingredients in Cymbalta should not take it. If you
have recently taken a type of antidepressant called a monoamine
oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine) or
have uncontrolled narrow- angle glaucoma, you should not take
Cymbalta. Talk with your doctor before taking Cymbalta if you have
liver or kidney problems, glaucoma or consume large quantities of
alcohol. Women who are pregnant should talk with their doctor
before taking Cymbalta. Nursing while taking Cymbalta is not
recommended. Tell your doctor if you are taking other prescription
or nonprescription medications. In clinical studies of Cymbalta for
depression, the most common side effects were nausea, dry mouth,
constipation, decreased appetite, fatigue, sleepiness, and
increased sweating. Nausea was the most common side effect. For
most people, the nausea was mild to moderate, and usually subsided
within one-to-two weeks. Cymbalta is also approved for the
management of neuropathic pain associated with diabetic peripheral
neuropathy. In clinical studies of Cymbalta in these patients, the
most common side effects were nausea, sleepiness, dizziness,
constipation, dry mouth, increased sweating, decreased appetite,
and loss of strength or energy. In all clinical trials, most people
were not bothered enough by side effects to stop taking Cymbalta.
Your doctor may periodically check your blood pressure. Don't stop
taking Cymbalta without talking to your doctor. For full Patient
Information, visit http://www.cymbalta.com/. For full Prescribing
Information, including Boxed Warning, visit
http://www.cymbalta.com/. Lexapro is a registered trademark of
Forest Pharmaceuticals, Inc. About Eli Lilly and Company Lilly, a
leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs. Additional information about
Lilly is available at http://www.lilly.com/. P-LLY This press
release contains forward-looking statements about the potential of
Cymbalta hydrochloride for the treatment of major depressive
disorder, and reflects Lilly's current beliefs. However, as with
any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
There is no guarantee that the product will prove to be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. (i) National Institute of Mental
Health. Depression Research at the National Institute of Mental
Health: Fact Sheet. Available at
http://www.nimh.nih.gov/publicat/depresfact.cfm. Accessed May 12,
2004. (ii) American Psychiatric Association. Diagnostic and
Statistical Manual of Mental Disorders. 4th ed., Text Revision.
Washington DC: American Psychiatric Association; 2000:345-428.
(iii) Kroenke K, et al. Am J Med. 1997; 103(5):339-347. (iv) Simon
GE, et al. N Engl J Med. 1999; 341(18):1329-1335. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Tamara Hull (US), +1-317-651-9116,
pager: +1-888-232-0785, or David Shaffer (OUS), +1-317-651-3710,
pager: +1-877-656-9084, both of Eli Lilly and Company
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